Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal

This study has been completed.
Sponsor:
Collaborator:
Graceway Pharmaceuticals, LLC
Information provided by (Responsible Party):
Keyvan Nouri, University of Miami
ClinicalTrials.gov Identifier:
NCT00638651
First received: March 12, 2008
Last updated: August 20, 2014
Last verified: August 2014
Results First Received: August 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Healthy
Interventions: Device: 1064 nm Nd:YAG laser
Drug: Imiquimod, 5% cream

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Laser Treatment With Imiquimod Cream (Group 1) The tattoo will be treated with laser and imiquimod 5% cream
Laser Treatment With Placebo Cream (Group 2) The tattoo will be treated with laser and placebo topical cream

Participant Flow:   Overall Study
    Laser Treatment With Imiquimod Cream (Group 1)     Laser Treatment With Placebo Cream (Group 2)  
STARTED     3     3  
COMPLETED     3     3  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Laser Treatment With Imiquimod Cream (Group 1)

The tattoo will be treated with laser and imiquimod 5% cream

1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy

Imiquimod, 5% cream: 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month

Laser Treatment With Placebo Cream (Group 2)

The tattoo will be treated with laser and placebo topical cream

1064 nm Nd:YAG laser: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy

Total Total of all reporting groups

Baseline Measures
    Laser Treatment With Imiquimod Cream (Group 1)     Laser Treatment With Placebo Cream (Group 2)     Total  
Number of Participants  
[units: participants]
  3     3     6  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     3     6  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     1     1     2  
Male     2     2     4  



  Outcome Measures

1.  Primary:   Efficacy of Tattoo Removal Using Topical Imiquimod 5% Cream   [ Time Frame: approximately 14 weeks ]

2.  Secondary:   Bleaching of the Tattoo   [ Time Frame: 14 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Keyvan Nouri
Organization: University of Miami
phone: 305-243-3380
e-mail: knouri@med.miami.edu


Publications of Results:

Responsible Party: Keyvan Nouri, University of Miami
ClinicalTrials.gov Identifier: NCT00638651     History of Changes
Other Study ID Numbers: 20071234
Study First Received: March 12, 2008
Results First Received: August 20, 2014
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration